A Kentucky jury has awarded eleven year old Breanna Sadler $7,246,227.64 following her being surgically implanted with an Advanced Bionics HiRes90k cochlear implant device that ultimately leaked.
The case, Sadler v. Advanced Bionics, was heard in the United States District Court for the Western District of Kentucky in Louisville (No. 3:11-CV-00450-TBR). It is the first case involving the Advanced Bionics HiRes90k cochlear implant that has been heard by a jury in the world. The parent company of Advanced Bionics is Sonova.
The lawsuit alleged that Advanced Bionics failed to test its medical device “under actual or simulated use conditions” to test reliability before the device was sold to the general public. The lawsuit also alleged the company made an unlawful switch in a critical component known as a feedthru without notice to the Food and Drug Administration (FDA). In reaching their verdict, the Kentucky jury of ten found that the product was defective and unreasonably dangerous, and that Advanced Bionics was negligent as to the manufacture and design of the class III medical device.
The jury also awarded punitive damages against Advanced Bionics, finding that the Sadler family proved by clear and convincing evidence that Advanced Bionics’ conduct was outrageous and showed a reckless indifference to Breanna Sadler and others. An Advanced Bionics reliability engineer testified in trial that there have been more than 1,000 device failures to date. The same employee testified that the projected failure rate of the Advanced Bionics HiRes90k device containing the vendor B feedthru could be as high as 45-50%.
“Breanna was unfortunately shocked and subjected to a great deal of needless pain and suffering” said Tim Edwards of Glassman, Edwards, Wyatt, Tuttle & Cox, P.C. (Memphis, TN), lead counsel for the Sadler Family. “The jury has spoken by announcing that medical device companies must properly test their products before sale.”
A cochlear implant is a medical device implanted in the head that restores a sense of sound to those,with severe hearing loss. Brian and Michelle Sadler filed a lawsuit on behalf of their daughter following an incident in 2009 when she was violently shocked by the device. “It is believed that more than 4,000 persons received the Advanced Bionics cochlear implant worldwide with the vendor B component,” said Ed Wallis of Memphis, who served as second chair to Sadler family. Also, a part of the trial team, were Kevin McCormack of Memphis and Ron Johnson of Fort Wright in Northern Kentucky.
LACI COMMENTS: The lawsuit alleged that Advanced Bionics failed to test its medical device “under actual or simulated use conditions”. This is taken directly from the FDA Quality System Regulation 21 CFR 820.30(g) associated with Design Validation. It is very interesting to see that the court system is actually utilizing the FDA regulation and citing it in an actual court case.
REFERENCE: LOUISVILLE, KY (PRWEB) April 19, 2013